Recall Z-2388-2018— GE Medical Systems, SCS

Name: FDA recall Z-2388-2018
Creator: U.S. Food and Drug Administration
Published: 2018-03-29

Class II · Terminated

Class II FDA medical device recall by GE Medical Systems, SCS, initiated 2018-03-29, terminated 2021-06-15. It names one FDA 510(k) clearance: K133278. Product: Discovery IGS 740 Interventional Fluoroscopic X-ray Systems. Reason: The Discovery IGS and Innova IGS systems may experience X-ray abort errors which could result in the loss of imaging mode before or during fluoroscopic use..

Recalling firm: GE Medical Systems, SCS
Classification: Class II
Status: Terminated
Initiated: 2018-03-29
Terminated: 2021-06-15
Firm location: Buc, France

510(k) clearances named in this recall

1 on FDA's record

K133278 — DISCOVERY IGS 740GE Medical Systems SCS·cleared 2014-04-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Discovery IGS 740 Interventional Fluoroscopic X-ray Systems

Reason for recall

The Discovery IGS and Innova IGS systems may experience X-ray abort errors which could result in the loss of imaging mode before or during fluoroscopic use.

Data sourced from openFDA. This site is unofficial and independent of the FDA.